Full-Time

Director – Global Safety Epidemiology

Posted on 9/10/2024

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

Senior

Cambridge, MA, USA + 1 more

More locations: Bethesda, MD, USA

70/30 work model requires 70% in-office presence.

Category
Public Health
Biology Lab & Research
Biology & Biotech
Required Skills
Data Analysis
Requirements
  • PhD in Epidemiology or related field is preferred, equivalent experience will be considered. Preference given to candidates with previous experience in use of real-world data to conduct post-authorization safety studies meeting international regulatory commitments.
  • Minimum 3 years’ experience in an industry setting, preferably in vaccines or a related therapeutic area.
  • Proven ability to: Plan and execute epidemiologic studies and related activities. Deliver high-quality results within established timelines. Lead cross-functional teams and work streams.
  • Experience in pharmacoepidemiology or prior research working with large electronic healthcare databases (e.g., EHR, administrative/claims data).
  • Able to conduct epidemiologic analyses in SAS.
  • Creative problem-solver with the ability to thrive in a fast-paced environment.
  • Attention to detail, internal drive to generate high-quality work, and sense of urgency to achieve team and program goals.
  • Excellent analytical, problem-solving, and strategic planning skills.
  • Strong interpersonal skills commensurate with the need to work closely with CROs, investigators, consultants, and Moderna team members across functions in a matrix environment.
  • Exceptional written and oral communication skills to meet the needs of varied audiences.
  • Integrated understanding of global regulatory authorities, ICH GCP, and GPP/GEP guidelines; prior interaction with major regulators and public health agencies is preferred.
Responsibilities
  • Provide epidemiologic input to questions related to product safety from multiple sources across the product lifecycle.
  • Design and execute observational studies concerning burden of disease for safety topics, safety surveillance in both spontaneous and population-based data sources, pregnancy safety, and prospective cohort event monitoring across diverse geographies.
  • Lead efforts to identify fit-for-purpose data to meet real-world evidence generation needs suitable for submission to international health authorities.
  • Set the scientific direction of studies and develop protocols, data analysis plans, study reports and peer-reviewed publications.
  • Present findings to diverse audience of internal and external stakeholders.
  • Lead or contribute to safety epidemiology content for regulatory plans/documents and aggregate reports. Interact with regulatory agencies and other external authorities as needed.
  • Contribute to epidemiologic knowledge in the external environment via abstracts, manuscripts, and presentations at academic conferences.
  • Contribute to the culture of quality and methodologic rigor in the design and execution of epidemiologic activities to the highest standard of quality and compliance.
  • Develop collaborations with external experts and investigators to facilitate epidemiologic evidence generation.
  • Develop and maintain strong, collaborative relationships with the broader Moderna organization.
  • Provide mentorship and guidance to junior epidemiologists and other team members, fostering a collaborative and innovative team environment.
  • Provide epidemiologic support to other Moderna epidemiology programs as needed.

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a crucial component in how cells produce proteins necessary for various biological functions. Their approach involves creating a new class of medicines that utilize mRNA to instruct cells to produce specific proteins, potentially leading to significant advancements in treatment options for patients. Unlike traditional pharmaceuticals, which often rely on small molecules or proteins, Moderna's mRNA-based therapies aim to enhance the discovery, development, and manufacturing processes of medicines. The company's goal is to leverage the unique properties of mRNA to improve patient outcomes and create a new category of effective treatments.

Company Stage

IPO

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

2010

Growth & Insights
Headcount

6 month growth

4%

1 year growth

16%

2 year growth

55%
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Simplify's Take

What believers are saying

  • Opening a new vaccine facility in Victoria enhances manufacturing capabilities.
  • Strategic investment in China boosts Moderna's presence in the Asian market.
  • Collaboration with Carisma Therapeutics could lead to breakthroughs in autoimmune treatments.

What critics are saying

  • Potential removal from Nasdaq 100 could impact investor perception.
  • Reticence in Hong Kong for Covid-19 jab indicates market penetration challenges.
  • Expansion into China may expose Moderna to geopolitical and regulatory risks.

What makes Moderna unique

  • Moderna is pioneering mRNA technology for innovative medical treatments.
  • The company has a strong focus on developing vaccines for infectious diseases.
  • Moderna's mRNA platform enables rapid development of therapeutics and vaccines.

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